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    NDC 72603-0191-01 sapropterin dihydrochloride 100 mg/1 Details

    sapropterin dihydrochloride 100 mg/1

    sapropterin dihydrochloride is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by NorthStar RxLLC. The primary component is SAPROPTERIN DIHYDROCHLORIDE.

    Product Information

    NDC 72603-0191
    Product ID 72603-191_0bad959e-817e-3055-e063-6294a90a7646
    Associated GPIs
    GCN Sequence Number 063484
    GCN Sequence Number Description sapropterin dihydrochloride TABLET SOL 100 MG ORAL
    HIC3 C7H
    HIC3 Description PKU TX AGENT-COFACTOR OF PHENYLALANINE HYDROXYLASE
    GCN 99211
    HICL Sequence Number 035266
    HICL Sequence Number Description SAPROPTERIN DIHYDROCHLORIDE
    Brand/Generic Generic
    Proprietary Name sapropterin dihydrochloride
    Proprietary Name Suffix n/a
    Non-Proprietary Name sapropterin dihydrochloride
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET
    Route ORAL
    Active Ingredient Strength 100
    Active Ingredient Units mg/1
    Substance Name SAPROPTERIN DIHYDROCHLORIDE
    Labeler Name NorthStar RxLLC
    Pharmaceutical Class Breast Cancer Resistance Protein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Phenylalanine Hydroxylase Activator [EPC], Phenylalanine Hydroxylase Activators [MoA]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA215534
    Listing Certified Through 2024-12-31

    Package

    NDC 72603-0191-01 (72603019101)

    NDC Package Code 72603-191-01
    Billing NDC 72603019101
    Package 120 TABLET in 1 BOTTLE (72603-191-01)
    Marketing Start Date 2023-12-01
    NDC Exclude Flag N
    Pricing Information N/A